Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk
Doctor Manzanilla Cough & Cold
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Doctor Manzanilla Allergy & Decongestant Relief
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: glass particulate found in vial
Class III · Low risk
Enalapril Maleate Tablets
Failed Stability Specifications
Class I · High risk
PIYANPING Anti-Itch
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Class III · Low risk
Propafenone Hydrochloride tablets
Failed moisture limits: Out of specification for moisture content.
Class II · Moderate risk
Choice Antibacterial Hand Soap
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Class II · Moderate risk
Mild Healthcare Antibacterial Hand Soap
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Class II · Moderate risk
Option Systems Antibacterial Foaming Hand Wash
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Class II · Moderate risk
Ketorolac Trom 30 mg/mL Injection
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Class II · Moderate risk
Levophed (norepinephrine bitartrate)
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class II · Moderate risk
HYDROmorphone HCl Injection
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class II · Moderate risk
Ninjacof-A
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II · Moderate risk
Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg)
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II · Moderate risk
Nose to Toes Skin Antisepsis
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Skin antisepsis and oral cleansing. Contains Three 2-packs of 2%…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products